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Senior Clinical Scientist, Early Clinical Development, Hematology/Oncology & Cell Therapy

Bristol Myers Squibb
US,CA,San Diego
$168K-$210K a year
Full-time

Description

The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

Position Summary / Objective :

Responsible for implementation, planning, and execution of assigned clinical trial activities.

Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.

Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership).

May support clinical development planning in collaboration with Early Clinical Development physician(s).

Position Responsibilities :

Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.

Plan and lead the implementation of clinical study startup / conduct / close-out activities as applicable.

Evaluate innovative trial designs in collaboration with the study physician.

Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication / resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing.

Present to governance committee and early clinical development team meetings as required.

Serve as primary contact for site-facing activities such as training and support for clinical questions.

Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review / query resolution;

ensure consistent, quality data review.

Identify clinical data trends; provide trends and escalate questions to study physician.

Develop clinical narrative plan and review clinical narratives.

Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.

Review / develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.

g., safety review) activities.

Author / review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).

Collaborate and serve as primary liaison between external partners for scientific advice.

Author / review abstracts, presentations, and manuscripts for external publications

Degree Requirements :

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).

Experience Requirements :

5+ years of experience in clinical science, clinical research, or equivalent.

Proficient knowledge of GCP / ICH, drug development process, study design, statistics, clinical operations.

Proficient knowledge and skills to support program specific data review, trend identification, data interpretation

Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

Key Competency Requirements :

Excellent verbal, written, communication and interpersonal skills.

Must be able to effectively communicate and collaborate across functions and job levels.

Ability to assimilate technical information quickly.

Routinely takes initiative.

Detail-oriented.

Strong sense of teamwork; ability to lead matrix team activities.

Proficient in Medical Terminology and medical writing skills.

Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK / PD, biomarker & safety profile).

Proficient critical thinking, problem solving, decision making skills.

Understanding of functional and cross-functional relationships.

Commitment to Quality.

Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.

Proficient planning / project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals).

Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools.

Domestic and international travel may be required (approximately 10-20%)

The starting compensation for this job is a range from $168,000 to $210,000 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care.

Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K).

Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.

Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.

Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement,fertility / infertilitybenefits, support for traveling mothers, and child, elder and pet care resources.

Other perks like tuition reimbursement and a recognition program.

LI - Hybrid

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to .

Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

30+ days ago
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